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First-in-Class Cholesterol-Lowering Drug Approved

First-in-Class Cholesterol-Lowering Drug Approved

The Food and Drug Administration (FDA) has approved Praluent (alirocumab; Sanofi Aventis and Regeneron) injection as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. Praluent is the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

The efficacy and safety of Praluent were evaluated in five placebo-controlled trials, involving 2,476 participants exposed to Praluent. All participants had HeFH or were otherwise at high risk for heart attack or stroke, and were taking maximally tolerated doses of a statin, with or without other lipid‑modifying therapies. Participants taking Praluent had an average reduction in LDL cholesterol ranging from 36–59%, compared to placebo. A trial evaluating the effect of adding Praluent to statins on reducing cardiovascular risk is ongoing.

Alirocumab is a human monoclonal antibody that binds to PCSK9. PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

Praluent will be available in pre-filled pens and pre-filled syringes in 75mg/mL or 150mg/mL strengths.